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NCT01871727 · ADVERSE EVENTS

Adverse events

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma · Source last updated 2024-11-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months)
Other-event reporting threshold
0%

Lead-In Part: SAS included all participants who received study drug. Main Study Part: SAS included all participants (both Main Study and Lead-In) who received study drug at 9 mcg/kg. As per planned analysis,all participants from lead-in part (9 mcg/kg) arm were reported together with the main study part participants (98=9 participants from 9 mcg/kg lead-in part and 90 participants from main study part) hence, data was reported for 98 participants as planned in main study part for this section.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lead-In Part: E7777 6 mcg/kg

Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.

0 / 22 / 20 / 2
Lead-In Part: E7777 12 mcg/kg

Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.

4 / 99 / 93 / 9
Lead-In Part: E7777 15 mcg/kg

Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.

2 / 21 / 20 / 2
Lead-In Part and Main Study Part: E7777 9 mcg/kg

Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.

36 / 9895 / 9813 / 98

Group identifiers: EG000: Lead-In Part: E7777 6 mcg/kg · EG001: Lead-In Part: E7777 12 mcg/kg · EG002: Lead-In Part: E7777 15 mcg/kg · EG003: Lead-In Part and Main Study Part: E7777 9 mcg/kg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      98
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Thyroiditis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Duodenal ulcer haemorrhage

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      98
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      98
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      98
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      98
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      98
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      98
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Eye inflammation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      98
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Angular cheilitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      98
    term
    Constipation
Complete source fields
description
Lead-In Part: SAS included all participants who received study drug. Main Study Part: SAS included all participants (both Main Study and Lead-In) who received study drug at 9 mcg/kg. As per planned analysis,all participants from lead-in part (9 mcg/kg) arm were reported together with the main study part participants (98=9 participants from 9 mcg/kg lead-in part and 90 participants from main study part) hence, data was reported for 98 participants as planned in main study part for this section.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Lead-In Part: E7777 6 mcg/kg
  2. deaths Num Affected
    3
    deaths Num At Risk
    9
    description
    Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    EG001
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Lead-In Part: E7777 12 mcg/kg
  3. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Lead-In Part: E7777 15 mcg/kg
  4. deaths Num Affected
    13
    deaths Num At Risk
    98
    description
    Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
    id
    EG003
    other Num Affected
    95
    other Num At Risk
    98
    serious Num Affected
    36
    serious Num At Risk
    98
    title
    Lead-In Part and Main Study Part: E7777 9 mcg/kg
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      98
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      98
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      98
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      98
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      98
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      98
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Eye inflammation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      98
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Angular cheilitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      98
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      98
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Thyroiditis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Duodenal ulcer haemorrhage
time Frame
From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice