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NCT04241315 · ADVERSE EVENTS

Adverse events

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting · Source last updated 2023-03-23

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
Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Near-Infrared Imaging Group

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system

7 / 10098 / 1000 / 100
No Imaging Group

All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

2 / 1111 / 110 / 11

Group identifiers: EG000: Near-Infrared Imaging Group · EG001: No Imaging Group

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      100
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Haemothorax
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      100
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pleural effusion
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dyspnoea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pulmonary air leakage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      100
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sepsis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      100
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Urinary tract infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hepatic haematoma
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hyperglycaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      100
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Urinary retention
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Subcutaneous emphysema

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      100
      num Events
      88
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      11
      num Events
      12
    term
    Procedural pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      100
      num Events
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      3
    term
    Incision site pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      100
      num Events
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Pneumothorax
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      100
      num Events
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Cough
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      100
      num Events
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dyspnoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      100
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hypoxia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      100
      num Events
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pleural effusion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      100
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pulmonary air leakage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      100
      num Events
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      2
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      100
      num Events
      17
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      100
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Hypertension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      100
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hypotension
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    100
    description
    All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system
    id
    EG000
    other Num Affected
    98
    other Num At Risk
    100
    serious Num Affected
    7
    serious Num At Risk
    100
    title
    Near-Infrared Imaging Group
  2. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    2
    serious Num At Risk
    11
    title
    No Imaging Group
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      100
      num Events
      88
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      11
      num Events
      12
    term
    Procedural pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      100
      num Events
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      3
    term
    Incision site pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      100
      num Events
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Pneumothorax
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      100
      num Events
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Cough
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      100
      num Events
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dyspnoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      100
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hypoxia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      100
      num Events
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pleural effusion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      100
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pulmonary air leakage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      100
      num Events
      26
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      2
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      100
      num Events
      17
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      100
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Hypertension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      100
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hypotension
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      100
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Haemothorax
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      100
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pleural effusion
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dyspnoea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pulmonary air leakage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      100
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sepsis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      100
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Urinary tract infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hepatic haematoma
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hyperglycaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      100
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Urinary retention
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      100
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Subcutaneous emphysema
time Frame
Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration

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