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NCT00920556 · ADVERSE EVENTS

Adverse events

A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma · Source last updated 2019-02-27

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 Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
Other-event reporting threshold
5%

SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SRT501

The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.

12 / 2424 / 242 / 24

Group identifiers: EG000: SRT501

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
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Sinus Bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    Disease progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Neutropenic sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Viral infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
    term
    Renal failure acute

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      24
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      24
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      24
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      24
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      24
    term
    Dyspepsia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      24
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      24
    term
    PYREXIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
    term
    OEDEMA PERIPHERAL
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    CHILLS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    DISEASE PROGRESSION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      24
    term
    HEADACHE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      24
    term
    NEUROPATHY PERIPHERAL
Complete source fields
description
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    24
    description
    The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.
    id
    EG000
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    12
    serious Num At Risk
    24
    title
    SRT501
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      24
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      24
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      24
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      24
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      24
    term
    Dyspepsia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      24
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      24
    term
    PYREXIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
    term
    OEDEMA PERIPHERAL
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    CHILLS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    DISEASE PROGRESSION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      24
    term
    HEADACHE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      24
    term
    NEUROPATHY PERIPHERAL
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Sinus Bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    Disease progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      24
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Neutropenic sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Viral infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 13.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
    term
    Renal failure acute
time Frame
From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)

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Preserved source evidence · Not medical advice