Event |
n=476(%) |
Adverse drug reactions |
|
|
Most frequent adverse drug reactions Hypercholesterolaemia Hypertriglyceridaemia Oedema Peripheral neuropathy Weight increase Cognitive effects Fatigue Arthralgia Diarrhoea Mood effects |
81.1 67.2 55.7 43.7 30.9 27.7 27.3 23.5 22.9 21.0 |
• Median duration of LORVIQUA® treatment was 16.3 months (range: 0 day to 55 months), the median age was 55 years (range: 19 to 90 years), and 25% of patients were older than 65 years. A total of 57% of patients were female, 50% of patients were White, 39% of patients were Asian, and 1% were Black. | |
Serious adverse drug reactions |
7.4% |
The most frequent serious adverse drug reactions were cognitive effects and pneumonitis. | |
Dose reductions |
20.0% |
The most frequent adverse reactions that led to dose reductions were oedema and peripheral neuropathy | |
Permanent discontinuations |
3.2% |
The most frequent adverse reactions that led to Permanent discontinuations of LORVIQUA® were cognitive effects peripheral neuropathy, and pneumonitis | |
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Adverse Drug Reactions by System Organ Class1
Adverse drug reactions for LORVIQUA® within each system organ class (SOC) by decreasing medical seriousness.
System Organ Class |
Adverse Drug Reaction |
Metabolism and nutrition disorders |
Hypercholesterolaemiaa Hypertriglyceridaemiab Hyperglycaemia |
Psychiatric disorders |
Mood effectsc Psychotic effectsd Mental status changes |
Nervous system disorders |
Cognitive effectse Peripheral neuropathyf Speech effectsg Sleep effectsh Seizures |
Eye disorders |
Vision disorderi |
Vascular disorders |
Hypertension |
Respiratory, thoracic and mediastinal disorders Content |
Pneumonitisj |
Gastrointestinal disorders |
Diarrhoea |
Musculoskeletal and connective tissue disorders |
Arthralgia |
General disorders and administration site conditions |
Oedemak |
Investigations |
Weight increased Lipase increased Amylase increased |
Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse drug reaction in the table above. Terms actually reported in the studies up to the data cut-off date (B7461001: 14May2019; B7461006: 20Mar2020) and contributing to the relevant adverse drug reaction are indicated in parentheses, as listed below.
a Hypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).
b Hypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).
c Mood effects (including affective disorder, affect lability, aggression, agitation, anger, anxiety, bipolar I disorder, depressed mood, depression, depressive symptom, euphoric mood, irritability, mania, mood altered, mood swings, panic attack, personality change, stress, suicidal ideation).
d Psychotic effects (including delusion, hallucination, hallucination auditory, hallucination visual, schizophreniform disorder).
e Cognitive effects (including events from SOC Nervous system disorders: amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC Psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder). Within these effects, terms from SOC Nervous system disorders were more frequently reported than terms from SOC Psychiatric disorders.
f Peripheral neuropathy (including burning sensation, dysaesthesia, formication, gait disturbance, hypoaesthesia, motor dysfunction, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paraesthesia, peripheral motor neuropathy, peripheral sensory neuropathy, peroneal nerve palsy, sensory disturbance).
g Speech effects (including dysarthria, slow speech, speech disorder).
h Sleep effects (including abnormal dreams, insomnia, nightmare, sleep disorder, sleep talking, somnambulism).
i Vision disorder (including diplopia, photophobia, photopsia, vision blurred, visual impairment, visual acuity reduced, vitreous floaters).
j Pneumonitis (including interstitial lung disease, lung opacity, pneumonitis).
k Oedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling).
l Fatigue (including asthenia, fatigue).
Hypercholesterolaemia/Hypertriglyceridaemia1
Central nervous system effects1
Cognitive effects |
27.7% |
|
Most frequent adverse drug reactions of any grade Memory impairment Most frequent adverse drug reactions of Grade 3 or 4 Cognitive disorder Confusional state |
11.3%
0.8% 1.7% |
Mood effects |
21.0% |
|
Most frequent adverse drug reactions of any grade Anxiety Most frequent adverse drug reactions of Grade 3 or 4 Irritability Depression |
6.5%
0.8% 0.4% |
Speech effects |
8.2% |
|
Most frequent adverse drug reactions of any grade Dysarthria Most frequent adverse drug reactions of Grade 3 or 4 Dysarthria Slow speech Speech disorder |
4.0%
0.2% 0.2% 0.2% |
Psychotic effects |
6.9% |
|
Most frequent adverse drug reactions of any grade Hallucination Most frequent adverse drug reactions of Grade 3 or 4 Hallucination auditory Hallucination visual |
2.9%
0.2% 0.2% |
• Median time to onset for cognitive, mood, speech, and psychotic effects was 109, 43, 49, and 23 days, respectively | |
• Median duration of cognitive, mood, speech, and psychotic effects was 223, 143, 147, and 78 days, respectively | |
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