Trial Outcomes & Findings for Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT NCT01733238)
NCT ID: NCT01733238
Last Updated: 2023-06-22
Results Overview
Subjects who had a best response of complete response or partial response as assessed by the investigator
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
39 months
Results posted on
2023-06-22
Participant Flow
The study was initiated in November 2012 and the first subject was enrolled on 22 January 2013. A total of 15 subjects were screened. Subjects were enrolled at oncology clinics in the USA.
Participant milestones
| Measure |
PNT2258
PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
PNT2258
n=13 Participants
PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
65.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 39 monthsPopulation: All subjects who received at least 1 dose of PNT2258
Subjects who had a best response of complete response or partial response as assessed by the investigator
Outcome measures
| Measure |
PNT2258
n=13 Participants
PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
|
|---|---|
|
Overall Response Rate
|
53.8 percentage of participants
Interval 25.1 to 80.8
|
SECONDARY outcome
Timeframe: 39 monthsPopulation: All subjects who received at least 1 dose of PNT2258
The time from Cycle 1 Day 1 until the date of lymphoma progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation
Outcome measures
| Measure |
PNT2258
n=13 Participants
PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
|
|---|---|
|
Progression-free Survival
|
9.5 months
Interval 2.4 to 32.4
|
Adverse Events
PNT2258
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PNT2258
n=13 participants at risk
PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Atrial fibrilation
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Anticoagulation drug level above therapeutic
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Cerebrovascular accident
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Psychiatric disorders
Mental status changes
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
Other adverse events
| Measure |
PNT2258
n=13 participants at risk
PNT2258 120 mg/m2 administered on days 1-5 of a 21-day cycle.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
92.3%
12/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Chills
|
61.5%
8/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Diarrhoea
|
61.5%
8/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Fatigue
|
61.5%
8/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Headache
|
61.5%
8/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Vomiting
|
53.8%
7/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
53.8%
7/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Abdominal pain
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Decreased appetite
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Dizziness
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Vascular disorders
Hypertension
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Psychiatric disorders
Insomina
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Pain
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Pyrexia
|
46.2%
6/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
38.5%
5/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
38.5%
5/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
38.5%
5/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Abdominal distension
|
30.8%
4/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.8%
4/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Fall
|
30.8%
4/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
30.8%
4/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
30.8%
4/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.8%
4/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Asthenia
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Erythema
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Vascular disorders
Hypotension
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Oedema peripheral
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Upper respiratory tract infection
|
23.1%
3/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Blood and lymphatic system disorders
Splenomegaly
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Angina pectoris
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Bradycardia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Cardiac failure congestive
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Cardiomegaly
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Left ventricular hypertrophy
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Mitral valve incompetence
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Supraventricular tachycardia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Ear and labyrinth disorders
Ear discomfort
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Eye disorders
Eyelid oedema
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Eye disorders
Photophobia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Eye disorders
Vision blurred
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Eye disorders
Xerophthalmia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Diverticulum
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Eructation
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Faecaloma
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Gingival cyst
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Lip disorder
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Salivary gland mass
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Gastrointestinal disorders
Tongue ulceration
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Application site erythema
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Chest pain
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Device occlusion
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Gait disturbance
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Inflammation
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Influenza like illness
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Infusion site erythema
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Infusion site extravasation
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Infusion site oedema
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Infusion site pain
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Local swelling
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Localised oedema
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Mucosal inflammation
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
General disorders
Performance status decreased
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Bacteraemia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Candida infection
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Cellulitis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Chronic sinusitis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Eye infection
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Fungal skin infection
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Groin infection
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Oral candidiasis
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Otitis media
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Sinusitis
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Tinea pedis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Infections and infestations
Vulvovaginal candidiasis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Accident
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Foot fracture
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Thermal burn
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Tongue injury
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Injury, poisoning and procedural complications
Tooth injury
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Blood creatinine increased
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Blood lactate dehydrogenase increased
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Blood phosphorus increased
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Blood urea increased
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Breath sounds abnormal
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Electrocardiogram QT prolonged
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
International normalised ratio increased
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hypermetabolism
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Lower extremity mass
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic adenoma
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Areflexia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Migraine
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Paraesthesia
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Nervous system disorders
Presyncope
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Psychiatric disorders
Agitation
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Psychiatric disorders
Anger
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Psychiatric disorders
Confusional state
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Renal and urinary disorders
Dysuria
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Renal and urinary disorders
Haematuria
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Renal and urinary disorders
Micturition urgency
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Renal and urinary disorders
Urge incontinence
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Reproductive system and breast disorders
Breast pain
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Blister
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis barbae
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Vascular disorders
Deep vein thrombosis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Vascular disorders
Haematoma
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Vascular disorders
Hot flush
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Vascular disorders
Hypertensive crisis
|
7.7%
1/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.4%
2/13 • Adverse events were collected until 30 days after the last dose of PNT2258 for each subject
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place