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NCT04099277 · ADVERSE EVENTS

Adverse events

A Study of LY3435151 in Participants With Solid Tumors · Source last updated 2021-08-31

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
Up to 4 Months
Other-event reporting threshold
0%

All randomized participants.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
10 mg LY3435151

Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.

1 / 22 / 20 / 2

Group identifiers: EG000: 10 mg LY3435151

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
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dehydration

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Vomiting
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Thoracic vertebral fracture
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Electrocardiogram qt prolonged
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Troponin i increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Hyperkalaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Tumour pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Anxiety
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dyspnoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Orthostatic hypotension
Complete source fields
description
All randomized participants.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    10 mg LY3435151
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Vomiting
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Thoracic vertebral fracture
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Electrocardiogram qt prolonged
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Troponin i increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Hyperkalaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Tumour pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Anxiety
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dyspnoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Orthostatic hypotension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dehydration
time Frame
Up to 4 Months

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Preserved source evidence · Not medical advice