Extraction form for project: Management of Infantile Epilepsies

Design Details

1. Study Design
2. Country
3. Total sample size
4. Intervention Type
5. Funding source

Arms

Arm NameArm Description
Levetiracetam

Arm Details

1. Sample size for arm
Levetiracetam
2. Inclusion Criteria
Levetiracetam
3. Exclusion Criteria
Levetiracetam
4. Treatment details
Levetiracetam

Sample Characteristics

1. Gender, number of male
Levetiracetam
2. Gender, percentage of male
Levetiracetam
3. Age at intervention (mean)
Levetiracetam
4. Age at intervention (SD)
Levetiracetam
5. Age at intervention (range)
Levetiracetam
6. Age at intervention (median)
Levetiracetam
7. Seizure types and/or etiology
Levetiracetam
8. Prior treatment
Levetiracetam
9. Comments
Levetiracetam

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalEffectivenessEpilepsy severity, marked improvement
  • All Participants
  • 5 months
CategoricalEffectivenessEpilepsy severity, moderate improvement
  • All Participants
  • 5 months
CategoricalEffectivenessEpilepsy severity, slight improvement
  • All Participants
  • 5 months
CategoricalEffectivenessEpilepsy severity, no change
  • All Participants
  • 5 months
CategoricalEffectivenessEpilepsy severity, slight worsening
  • All Participants
  • 5 months
CategoricalEffectivenessEpilepsy severity, moderate worsening
  • All Participants
  • 5 months
CategoricalEffectivenessEpilepsy severity, marked worsening
  • All Participants
  • 5 months
CategoricalEffectivenessPsychomotor development, marked improvement
  • All Participants
  • 5 months
CategoricalEffectivenessPsychomotor development, moderate improvement
  • All Participants
  • 5 months
CategoricalEffectivenessPsychomotor development, slight improvement
  • All Participants
  • 5 months
CategoricalEffectivenessPsychomotor development, no change
  • All Participants
  • 5 months
CategoricalEffectivenessPsychomotor development, slight worsening
  • All Participants
  • 5 months
CategoricalEffectivenessPsychomotor development, moderate worsening
  • All Participants
  • 5 months
CategoricalEffectivenessPsychomotor development, marked worsening
  • All Participants
  • 5 months
CategoricalAdverse EventAdverse event requiring dose change
  • All Participants
  • 5 months
CategoricalAdverse EventBronchiolitis
  • All Participants
  • 5 months
CategoricalAdverse EventBronchitis
  • All Participants
  • 5 months
CategoricalAdverse EventConstipation
  • All Participants
  • 5 months
CategoricalAdverse EventConvulsion
  • All Participants
  • 5 months
CategoricalAdverse EventDeath unrelated to study drug according to investigators
  • All Participants
  • 5 months
CategoricalAdverse EventDiarrhea
  • All Participants
  • 5 months
CategoricalAdverse EventDrug-related adverse event
  • All Participants
  • 5 months
CategoricalAdverse EventEar infection
  • All Participants
  • 5 months
CategoricalAdverse EventEpilepsy
  • All Participants
  • 5 months
CategoricalAdverse EventGastroenteritis
  • All Participants
  • 5 months
CategoricalAdverse EventGastro-oesophageal reflux disease
  • All Participants
  • 5 months
CategoricalAdverse EventHypotonia
  • All Participants
  • 5 months
CategoricalAdverse EventInfantile spasm
  • All Participants
  • 5 months
CategoricalAdverse EventIrritability
  • All Participants
  • 5 months
CategoricalAdverse EventLower respiratory tract infection
  • All Participants
  • 5 months
CategoricalAdverse EventNasopharyngitis
  • All Participants
  • 5 months
CategoricalAdverse EventFever
  • All Participants
  • 5 months
CategoricalAdverse EventRespiratory disorder
  • All Participants
  • 5 months
CategoricalAdverse EventRespiratory distress
  • All Participants
  • 5 months
CategoricalAdverse EventSerious adverse event (any)
  • All Participants
  • 5 months
CategoricalAdverse EventSevere treatment related adverse event
  • All Participants
  • 5 months
CategoricalAdverse EventUpper respiratory tract infection
  • All Participants
  • 5 months
CategoricalAdverse EventUrinary tract infection
  • All Participants
  • 5 months
CategoricalAdverse EventViral infection
  • All Participants
  • 5 months
CategoricalAdverse EventVomiting
  • All Participants
  • 5 months
CategoricalAdverse EventWithdrawal due to AE
  • All Participants
  • 5 months

Outcome Details

1. For RCTs: Generation of randomization sequence
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2. For RCTs: Allocation concealment
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3. For RCTs: Baseline imbalance
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4. For RCTs: Patient blinded
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5. For RCTs: Staff blinded
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6. For RCTs: Differential ancillary treatments
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7. For RCTs: Adherence
Effectiveness
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8. For RCTs: Analytic approach to address departures from intended intervention
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9. For RCTs: Data on at least 80% of those enrolled
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10. For RCTs: Differential dropout <=15%
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11. For RCTs: Standard way to measure the outcome
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12. For RCTs: Blinded outcome assessor
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13. For RCTs: Bias in selection of reported results
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14. For nonrandomized comparative studies: Confounding
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15. For nonrandomized comparative studies: Selection into study
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16. For nonrandomized comparative studies: Classification of interventions
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17. For nonrandomized comparative studies: Differential ancillary treatments
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18. For nonrandomized comparative studies: Adherence
Effectiveness
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19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Effectiveness
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20. For nonrandomized comparative studies: Differential dropout <=15%
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21. For nonrandomized comparative studies: Standard way to measure the outcome
Effectiveness
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Effectiveness