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NCT02603172 · ADVERSE EVENTS

Adverse events

A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis · Source last updated 2019-09-23

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
Part A: Up to Day 14; Part B (Cohort 3: Up to Day 21, Cohort 4a and 4b: Up to Day 35); and Part C: Up to Day 63
Other-event reporting threshold
5%

Safety population was analyzed which consisted of all participants who received at least one dose of the study medication. The study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4A and 4B were not recruited in Part B and Part C was not initiated.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: GSK3039294 200 mg

Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.

0 / 81 / 80 / 8
Part A: GSK3039294 600 mg

Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.

0 / 166 / 160 / 16
Part A: GSK3039294 1200 mg

Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.

0 / 85 / 80 / 8
Part B: Cohort 3- GSK3039294 600 mg QD

Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.

1 / 87 / 80 / 8
Part B: Cohort 4a- GSK3039294

Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).

0 / 00 / 00 / 0
Part B: Cohort 4b- GSK3039294

Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).

0 / 00 / 00 / 0
Part C: GSK3039294

Participants were planned to receive repeat dosing of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.

0 / 00 / 00 / 0

Group identifiers: EG000: Part A: GSK3039294 200 mg · EG001: Part A: GSK3039294 600 mg · EG002: Part A: GSK3039294 1200 mg · EG003: Part B: Cohort 3- GSK3039294 600 mg QD · EG004: Part B: Cohort 4a- GSK3039294 · EG005: Part B: Cohort 4b- GSK3039294 · EG006: Part C: GSK3039294

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
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Supraventricular tachycardia

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
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Atrial tachycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Accelerated idioventricular rhythm
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Supraventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Gastroenteritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dizziness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Eye irritation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Catheter site haematoma
Complete source fields
description
Safety population was analyzed which consisted of all participants who received at least one dose of the study medication. The study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4A and 4B were not recruited in Part B and Part C was not initiated.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    8
    serious Num Affected
    0
    serious Num At Risk
    8
    title
    Part A: GSK3039294 200 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    16
    serious Num Affected
    0
    serious Num At Risk
    16
    title
    Part A: GSK3039294 600 mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    8
    serious Num Affected
    0
    serious Num At Risk
    8
    title
    Part A: GSK3039294 1200 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    1
    serious Num At Risk
    8
    title
    Part B: Cohort 3- GSK3039294 600 mg QD
  5. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Part B: Cohort 4a- GSK3039294
  6. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Part B: Cohort 4b- GSK3039294
  7. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Participants were planned to receive repeat dosing of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
    id
    EG006
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Part C: GSK3039294
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Atrial tachycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Accelerated idioventricular rhythm
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Supraventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Gastroenteritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dizziness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Eye irritation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Catheter site haematoma
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Supraventricular tachycardia
time Frame
Part A: Up to Day 14; Part B (Cohort 3: Up to Day 21, Cohort 4a and 4b: Up to Day 35); and Part C: Up to Day 63

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice